Study group for Atrio-Esophageal Fistula

Phase-Based Progress Estimates
Texas Cardiac Arrhythmia Research Foundation, Austin, TXAtrio-Esophageal Fistula+2 MoreensoETM. Esophageal cooling during AF ablation - Device
18 - 85
All Sexes
What conditions do you have?

Study Summary

This trial will test if a cooling probe can protect the oesophagus during ablation, reducing the risk of severe oesophageal damage in AF patients.

Eligible Conditions
  • Atrial Fibrillation
  • Atrio-Esophageal Fistula
  • Complications

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Measured 4 times, at times: 0, 3, 6, 12 months from time of ablation.

Month 12
Incidence of major adverse events (MACCE) at times 0, 3, 6, 12 months.
Month 24
Recurrence of treated atrial arrhythmia (AF or related AT)
Month 3
Incidence of clinically significant chest/gastroenterological symptoms post ablation
Day 0
Ability to attain procedural endpoints during AF ablation.
Day 0
Fluoroscopy duration (minutes)
Procedure duration (minutes).
Hour 72
Incidence and severity of endoscopically detected oesophageal thermal injury related to AF ablation. (Endoscopy at times 12-72 hours).

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Study group
1 of 2
Control group
1 of 2

Active Control

500 Total Participants · 2 Treatment Groups

Primary Treatment: Study group · No Placebo Group · N/A

Study group
ActiveComparator Group · 1 Intervention: ensoETM. Esophageal cooling during AF ablation · Intervention Types: Device
Control group
ActiveComparator Group · 1 Intervention: Esophageal temperature monitoring probe · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: measured 4 times, at times: 0, 3, 6, 12 months from time of ablation.

Who is running the clinical trial?

Texas Cardiac Arrhythmia Research FoundationOTHER
37 Previous Clinical Trials
12,880 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
782 Previous Clinical Trials
845,599 Total Patients Enrolled
Virginia Commonwealth UniversityOTHER
631 Previous Clinical Trials
367,037 Total Patients Enrolled
University of Colorado, DenverOTHER
1,607 Previous Clinical Trials
1,930,953 Total Patients Enrolled
Attune MedicalOTHER
4 Previous Clinical Trials
221 Total Patients Enrolled
Advanced Cooling Therapy, Inc., d/b/a Attune MedicalLead Sponsor
6 Previous Clinical Trials
115 Total Patients Enrolled
St. George's Hospital, LondonOTHER
14 Previous Clinical Trials
5,048 Total Patients Enrolled
University of PennsylvaniaOTHER
1,870 Previous Clinical Trials
41,145,960 Total Patients Enrolled
Berry ConsultantsOTHER
7 Previous Clinical Trials
54,301 Total Patients Enrolled
National Health Service, United KingdomOTHER_GOV
57 Previous Clinical Trials
29,535 Total Patients Enrolled
Mark M Gallagher, MDPrincipal InvestigatorSt. George's NHS Trust
1 Previous Clinical Trials
120 Total Patients Enrolled
David Callans, MDPrincipal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
20 Total Patients Enrolled

Eligibility Criteria

Age 18 - 85 · All Participants · 1 Total Inclusion Criteria

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Frequently Asked Questions

Does this research trial have an age restriction, specifically for those over 65?

"For this clinical trial, only participants of legal age and under 85 years old can be recruited." - Anonymous Online Contributor

Unverified Answer

Is recruitment currently ongoing for this trial?

"As listed on, the recruitment of participants for this study is currently underway. This experimental trial was first opened to public scrutiny on March 10th 2022 and has recently been updated with new information as of February 15th 2023." - Anonymous Online Contributor

Unverified Answer

What is the aggregate number of clinical centers administering this trial?

"Several clinical trial sites are offering this medication, such as the Beth Israel Deaconess Medical Center in Boston, University of Pennsylvania in Philadelphia, and Texas Cardiac Arrhythmia Research Foundation in Austin. An additional 5 locations can also be found across America." - Anonymous Online Contributor

Unverified Answer

Can I sign up for this experiment?

"This medical trial seeks to recruit 500 individuals, aged between 18 and 85 years old, who are currently suffering from atrio-esophageal fistula. In addition, they must meet the necessary requirements for AF ablation treatment (general anaesthesia) as indicated by international standards. Moreover, participants must have already decided on undergoing this procedure prior to joining the study." - Anonymous Online Contributor

Unverified Answer

What is the current count of participants in this clinical experiment?

"This trial, managed by Advanced Cooling Therapy Inc. (Attune Medical), requires 500 patients who meet the pre-set qualifications to be recruited from a range of medical centres - such as Beth Israel Deaconess in Boston and University of Pennsylvania in Philadelphia." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.